B.C. health ministry shut down drug review, leaked email says

Jonathan Fowlie, Vancouver Sun07.09.2013

The order to shut down a review came on the same day an Ontario court had certified a class action against Pfizer Canada, Champix’s manufacturer, alleging the drug led to psychological side effects as severe as potential suicide. The claims have not been proven in court.

VICTORIA — The B.C. Ministry of Health last year shut down an independent review of Champix, a controversial anti-smoking drug that it provides to anyone wanting to quit, a leaked email released Tuesday by the New Democratic Party shows.

The order came on the same day an Ontario court had certified a class action against Pfizer Canada, the drug’s manufacturer, alleging Champix led to psychological side effects as severe as potential suicide. The claims have not been proven in court.

“We’ve decided to keep (the review of) smoking cessation in-house, sorry about that,” said an email written to a team of independent researchers by Rebecca Warburton, who at the time was co-director of the ministry’s drug research division.

“It’s getting political and we aren’t sure anyone wants to see a published evaluation,” wrote Warburton, who was fired in October 2012 along with six other ministry employees as part of an investigation into alleged breaches of sensitive data.

Warburton was writing in June 2012 to Greg Carney, research program director of the Therapeutics Initiative, an independent drug-therapy assessment organization, who had submitted a proposal to government to conduct an independent review of Champix.

Through a smoking-cessation program launched by Premier Christy Clark on Sept. 30, 2011, Pharmacare covers the prescription drugs varenicline (Champix) and bupropion (Zyban). These drugs do not contain nicotine, but work on the brain to manage withdrawal symptoms and cravings and reduce the urge to smoke.

Controversy had been mounting over the psychiatric drug varenicline at the time and, in June 2011, the French government had pulled the plug on funding it through public health insurance.

On Tuesday, a ministry official said 131,000 people have participated in the smoking cessation program since it began, and 45,000 of those have been prescribed Champix,

Health Minister Terry Lake said he had not seen the Warburton email, and therefore would not respond to a suggestion the ministry suppressed an independent review.

“I haven’t seen the email so I don’t really want to comment on it, but of course if such an email exists I would be interested to see it and understand the reasoning behind it,” said Lake, adding Champix had a rigorous review before seeing use in B.C.

“This drug, as all drugs we look at, goes through a common drug review nationally. That’s based on evidence-based decisions from the research that’s conducted internationally and nationally,” he said, adding it is approved in six other provinces.

“We’re not going to, obviously, have a drug there that is causing harm but I would tell people this is a doctor-patient decision,” he added.

“Physicians are fully informed about all of this kind of information and certainly they have the best ability to inform their patients as to the best course of action.”

On Tuesday, Carney said the Warburton email came as a surprise because a few months before, the government had told his organization it was very interested in a review of Champix.

He said he assumed from Warburton’s email that she had been given direction from above.

“When you are told something is political, you assume it comes from a very high level,” he said in an interview. “We assumed it had come from a level higher than Rebecca. Of course, we don’t know that for sure.”

New Democratic Party leader Adrian Dix, who publicly released the email, accused the government of suppressing an independent review because Champix was part of Clark’s high-profile smoking cessation program, which she had promised during her leadership campaign, and enacted after taking over as premier.

“What it says is that the government, because of politics, did not want to see a published evaluation of a drug program tied to the premier,” he told reporters Tuesday, calling the move both “disgraceful” and “scandalous.”

“Unless the premier has studied pharmacy somewhere that we’re not aware of, these are the premier’s politics and to behave in this way is simply scandalous.”

Warburton, who is suing government for wrongful dismissal, could not be reached for comment.

Carney added this was the first time government instructed his organization not to study a drug.

He said not long after the email arrived, the ministry cut the Therapeutics Initiative off from access to research data. This came as part of an investigation into alleged misuse of data, he said, adding he has no idea if there is any connection.

“That email from Rebecca came in June and all our data access was cut off in July, and we’ve still to this day not been told why,” he said. “We have no idea why we’re even involved in this investigation.”

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B.C. health ministry shut down drug review, leaked email says

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